How can the Quality of Medical Data in Pharmacovigilance, Pharmacoepidemiology and Clinical Studies be Guaranteed?
Identifieur interne : 001576 ( Main/Exploration ); précédent : 001575; suivant : 001577How can the Quality of Medical Data in Pharmacovigilance, Pharmacoepidemiology and Clinical Studies be Guaranteed?
Auteurs : François Alla [France] ; Myriam Rosilio [France] ; Christian Funck-Brentano [France] ; Philippe Barthélémy [France] ; Sophie Brisset [France] ; Dominic Cellier [France] ; Olivier Chassany [France] ; Jean-Paul Demarez [France] ; Vincent Diebolt [France] ; Alain Francillon [France] ; Laetitia Gambotti [France] ; Hakima Hannachi [France] ; Philippe Lechat [France] ; François Lemaire [France] ; Michel Lièvre [France] ; Christophe Misse [France] ; Marina Nguon [France] ; Antoine Pariente [France] ; Michel Rosenheim [France] ; Nadine Weisslinger-Darmon [France]Source :
- Thérapie [ 0040-5957 ] ; 2013-08-28.
Abstract
The development of medicinal products is subject to quality standards aimed at guaranteeing that database contents accurately reflect the source documents. Paradoxically, these standards hardly address the quality of the source data itself. The objective of this work was to propose recommendations to improve data quality in three fields (pharmacovigilance, pharmacoepidemiology and clinical studies). The analysis was focused on the data and on the critical stages presenting critical quality problems, for which the current guidelines are insufficiently detailed, unsuitable and/or poorly applied. Finally, recommendations have been proposed, mainly focused on the origin of the data and its transcription.
Url:
DOI: 10.2515/therapie/2013040
Affiliations:
- France
- Aquitaine, Auvergne-Rhône-Alpes, Grand Est, Lorraine (région), Midi-Pyrénées, Nouvelle-Aquitaine, Occitanie (région administrative), Rhône-Alpes, Île-de-France
- Bordeaux, Castres, Lyon, Nancy, Paris, Toulouse, Vandœuvre-lès-Nancy
- Université Pierre-et-Marie-Curie, Université de Lorraine
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Pharmacoepidemiology and Clinical Studies be Guaranteed?</title><author><name sortKey="Alla, Francois" sort="Alla, Francois" uniqKey="Alla F" first="François" last="Alla">François Alla</name><affiliation wicri:level="4"><country xml:lang="fr">France</country><wicri:regionArea>Université de Lorraine, Nancy</wicri:regionArea><placeName><region type="region">Grand Est</region><region type="old region">Lorraine (région)</region><settlement type="city">Nancy</settlement></placeName><orgName type="university">Université de Lorraine</orgName></affiliation><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Correspondence and offprints: François Alla, Centre d’Épidémiologie clinique, Inserm-CHU de Nancy, Allée du Morvan, 54500 Vandœuvre-les-Nancy</wicri:regionArea><placeName><region type="region" nuts="2">Grand Est</region><region type="old region" nuts="2">Lorraine (région)</region><settlement type="city">Vandœuvre-lès-Nancy</settlement></placeName></affiliation></author><author><name sortKey="Rosilio, Myriam" sort="Rosilio, Myriam" uniqKey="Rosilio M" first="Myriam" last="Rosilio">Myriam Rosilio</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Laboratoire Lilly France, Neuilly-sur-Seine</wicri:regionArea><wicri:noRegion>Neuilly-sur-Seine</wicri:noRegion><wicri:noRegion>Neuilly-sur-Seine</wicri:noRegion></affiliation></author><author><name sortKey="Funck Brentano, Christian" sort="Funck Brentano, Christian" uniqKey="Funck Brentano C" first="Christian" last="Funck-Brentano">Christian Funck-Brentano</name><affiliation wicri:level="4"><country xml:lang="fr">France</country><wicri:regionArea>Université Pierre et Marie Curie, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Pierre-et-Marie-Curie</orgName></affiliation></author><author><name sortKey="Barthelemy, Philippe" sort="Barthelemy, Philippe" uniqKey="Barthelemy P" first="Philippe" last="Barthélémy">Philippe Barthélémy</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Laboratoire AstraZeneca, Rueil-Malmaison</wicri:regionArea><wicri:noRegion>Rueil-Malmaison</wicri:noRegion><wicri:noRegion>Rueil-Malmaison</wicri:noRegion></affiliation></author><author><name sortKey="Brisset, Sophie" sort="Brisset, Sophie" uniqKey="Brisset S" first="Sophie" last="Brisset">Sophie Brisset</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Laboratoire Ax-Pharma, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Cellier, Dominic" 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Demarez</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Laboratoire Pierre Fabre Médicament, Castres</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Castres</settlement></placeName></affiliation></author><author><name sortKey="Diebolt, Vincent" sort="Diebolt, Vincent" uniqKey="Diebolt V" first="Vincent" last="Diebolt">Vincent Diebolt</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>F-CRIN, Toulouse</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Francillon, Alain" sort="Francillon, Alain" uniqKey="Francillon A" first="Alain" last="Francillon">Alain Francillon</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Laboratoire Novartis, Rueil-Malmaison</wicri:regionArea><wicri:noRegion>Rueil-Malmaison</wicri:noRegion><wicri:noRegion>Rueil-Malmaison</wicri:noRegion></affiliation></author><author><name sortKey="Gambotti, Laetitia" sort="Gambotti, Laetitia" uniqKey="Gambotti L" first="Laetitia" last="Gambotti">Laetitia Gambotti</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>URC Pitié-Salpétrière, AP-HP, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Hannachi, Hakima" sort="Hannachi, Hakima" uniqKey="Hannachi H" first="Hakima" last="Hannachi">Hakima Hannachi</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Laboratoire Merck Sharp Dohme, 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type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Lievre, Michel" sort="Lievre, Michel" uniqKey="Lievre M" first="Michel" last="Lièvre">Michel Lièvre</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Pharmacologie clinique, CHU, Lyon</wicri:regionArea><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Misse, Christophe" sort="Misse, Christophe" uniqKey="Misse C" first="Christophe" last="Misse">Christophe Misse</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>DRCD, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Nguon, Marina" 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last="Rosenheim">Michel Rosenheim</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Assistance Publique – Hôpitaux de Paris, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Weisslinger Darmon, Nadine" sort="Weisslinger Darmon, Nadine" uniqKey="Weisslinger Darmon N" first="Nadine" last="Weisslinger-Darmon">Nadine Weisslinger-Darmon</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Laboratoire GlaxoSmithKline, Marly-le-Roi</wicri:regionArea><wicri:noRegion>Marly-le-Roi</wicri:noRegion><wicri:noRegion>Marly-le-Roi</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Thérapie</title><title level="j" type="issue">XXVIIIes Rencontres Nationales de Pharmacologie et Recherche Clinique, Innovation et Évaluation des Technologies de Santé, Tables rondes GIENS – 7 au 9 octobre 2012</title><title level="j" type="abbrev">Therapie</title><title level="j" type="publisher-id">therapie</title><idno type="ISSN">0040-5957</idno><idno type="eISSN">1958-5578</idno><imprint><publisher>EDP Sciences</publisher><date type="Final-Published" when="2013-08-28">2013-08-28</date><date type="ePublished" when="2013-08-28">2013-08-28</date><date type="Published" when="2013-07">2013-07</date><biblScope unit="vol">68</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="217">217</biblScope><biblScope unit="page" to="223">223</biblScope><biblScope unit="page-count">7</biblScope><biblScope unit="ref-count">21</biblScope></imprint><idno type="ISSN">0040-5957</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0040-5957</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The development of medicinal products is subject to quality standards aimed at guaranteeing that database contents accurately reflect the source documents. Paradoxically, these standards hardly address the quality of the source data itself. The objective of this work was to propose recommendations to improve data quality in three fields (pharmacovigilance, pharmacoepidemiology and clinical studies). The analysis was focused on the data and on the critical stages presenting critical quality problems, for which the current guidelines are insufficiently detailed, unsuitable and/or poorly applied. Finally, recommendations have been proposed, mainly focused on the origin of the data and its transcription.</div></front></TEI><affiliations><list><country><li>France</li></country><region><li>Aquitaine</li><li>Auvergne-Rhône-Alpes</li><li>Grand Est</li><li>Lorraine (région)</li><li>Midi-Pyrénées</li><li>Nouvelle-Aquitaine</li><li>Occitanie (région administrative)</li><li>Rhône-Alpes</li><li>Île-de-France</li></region><settlement><li>Bordeaux</li><li>Castres</li><li>Lyon</li><li>Nancy</li><li>Paris</li><li>Toulouse</li><li>Vandœuvre-lès-Nancy</li></settlement><orgName><li>Université Pierre-et-Marie-Curie</li><li>Université de Lorraine</li></orgName></list><tree><country name="France"><region name="Grand Est"><name sortKey="Alla, Francois" sort="Alla, Francois" uniqKey="Alla F" first="François" last="Alla">François Alla</name></region><name sortKey="Alla, Francois" sort="Alla, Francois" uniqKey="Alla F" first="François" last="Alla">François Alla</name><name sortKey="Barthelemy, Philippe" sort="Barthelemy, Philippe" uniqKey="Barthelemy P" first="Philippe" last="Barthélémy">Philippe Barthélémy</name><name sortKey="Brisset, Sophie" sort="Brisset, Sophie" uniqKey="Brisset S" first="Sophie" last="Brisset">Sophie Brisset</name><name sortKey="Cellier, Dominic" sort="Cellier, Dominic" uniqKey="Cellier D" first="Dominic" last="Cellier">Dominic Cellier</name><name sortKey="Chassany, Olivier" sort="Chassany, Olivier" uniqKey="Chassany O" first="Olivier" last="Chassany">Olivier Chassany</name><name sortKey="Demarez, Jean Paul" sort="Demarez, Jean Paul" uniqKey="Demarez J" first="Jean-Paul" last="Demarez">Jean-Paul Demarez</name><name sortKey="Diebolt, Vincent" sort="Diebolt, Vincent" uniqKey="Diebolt V" first="Vincent" last="Diebolt">Vincent Diebolt</name><name sortKey="Francillon, Alain" sort="Francillon, Alain" uniqKey="Francillon A" first="Alain" last="Francillon">Alain Francillon</name><name sortKey="Funck Brentano, Christian" sort="Funck Brentano, Christian" uniqKey="Funck Brentano C" first="Christian" last="Funck-Brentano">Christian Funck-Brentano</name><name sortKey="Gambotti, Laetitia" sort="Gambotti, Laetitia" uniqKey="Gambotti L" first="Laetitia" last="Gambotti">Laetitia Gambotti</name><name sortKey="Hannachi, Hakima" sort="Hannachi, Hakima" uniqKey="Hannachi H" first="Hakima" last="Hannachi">Hakima Hannachi</name><name sortKey="Lechat, Philippe" sort="Lechat, Philippe" uniqKey="Lechat P" first="Philippe" last="Lechat">Philippe Lechat</name><name sortKey="Lemaire, Francois" sort="Lemaire, Francois" uniqKey="Lemaire F" first="François" last="Lemaire">François Lemaire</name><name sortKey="Lievre, Michel" sort="Lievre, Michel" uniqKey="Lievre M" first="Michel" last="Lièvre">Michel Lièvre</name><name sortKey="Misse, Christophe" sort="Misse, Christophe" uniqKey="Misse C" first="Christophe" last="Misse">Christophe Misse</name><name sortKey="Nguon, Marina" sort="Nguon, Marina" uniqKey="Nguon M" first="Marina" last="Nguon">Marina Nguon</name><name sortKey="Pariente, Antoine" sort="Pariente, Antoine" uniqKey="Pariente A" first="Antoine" last="Pariente">Antoine Pariente</name><name sortKey="Rosenheim, Michel" sort="Rosenheim, Michel" uniqKey="Rosenheim M" first="Michel" last="Rosenheim">Michel Rosenheim</name><name sortKey="Rosilio, Myriam" sort="Rosilio, Myriam" uniqKey="Rosilio M" first="Myriam" last="Rosilio">Myriam Rosilio</name><name sortKey="Weisslinger Darmon, Nadine" sort="Weisslinger Darmon, Nadine" uniqKey="Weisslinger Darmon N" first="Nadine" last="Weisslinger-Darmon">Nadine Weisslinger-Darmon</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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